Batch Record Specialist | Specialist Batch Record (w/m/d)
Brunel GmbH NL Frankfurt
Job Summary
As a Batch Record Specialist, you will play a critical role in the pharmaceutical manufacturing process by ensuring all production documentation adheres to strict Good Manufacturing Practice (GMP) standards. Your daily responsibilities involve reviewing and processing batch documentation, coordinating corrections with production departments, and managing manufacturing instructions. You will also be instrumental in preparing for GMP audits, updating Standard Operating Procedures (SOPs), and conducting staff training. A key part of the role includes utilizing electronic systems like MES and SAP to analyze batch data for process optimization and assisting in the implementation of new Electronic Batch Record (EBR) systems. This position is ideal for professionals seeking a stable, permanent role within a globally recognized engineering service provider, offering a collaborative culture, continuous professional development, and the chance to work with prestigious clients across the pharmaceutical industry.
Required Skills
Education
Degree in Biotechnology or a comparable field; alternatively, a completed vocational training with relevant professional experience.
Experience
- Professional experience in pharmaceutical manufacturing or a GMP-regulated environment
- Experience in checking and processing batch documentation and manufacturing instructions
- Proven experience working with MES and SAP software systems
- Experience in creating and revising SOPs and conducting technical training
- Experience participating in GMP audits and regulatory inspections
Languages
Additional
- Permanent full-time contract; 30 days of vacation; location-based role within the DACH-CZ region.
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